Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Public ClinicalTrials.gov record NCT02256488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.
Study identification
- NCT ID
- NCT02256488
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,561 participants
Conditions and interventions
Conditions
Interventions
- TIVc_LOT A Biological
- TIVc_LOT B Biological
- TIVc_LOT C Biological
- TIVf Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2014 (Type not available)
- Primary completion
- Dec 2014 (Actual)
- Completion
- Dec 2014 (Actual)
- Last update posted
- Jun 11, 2019
2014
United States locations
- U.S. sites
- 24
- U.S. states
- 14
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clincial Trials | Anaheim | California | — | — |
| Northern California Clinical Research Center | Redding | California | — | — |
| Southern California CRC | San Diego | California | — | — |
| Broward Research Group | Hollywood | Florida | — | — |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | — | — |
| Palm Bech Research | West Palm Beach | Florida | — | — |
| Meridian Clinical Research | Savannah | Georgia | — | — |
| Johnson County Clin-Trials, LLC | Lenexa | Kansas | — | — |
| Heartland Research Associates, LLC | Wichita | Kansas | — | — |
| Milford Emergency Associate,Inc | Milford | Massachusetts | — | — |
| Meridian Clinical Research | Omaha | Nebraska | — | — |
| Rochester Clinical Research, Inc | Rochester | New York | — | — |
| PMG Research of Charlotte | Charlotte | North Carolina | — | — |
| PMG Research of Hickory | Hickory | North Carolina | — | — |
| PMG Research of Raleigh | Raleigh | North Carolina | — | — |
| New Horizons Clinical Research | Cincinnati | Ohio | — | — |
| Columbia Research Group, Inc | Portland | Oregon | — | — |
| Omega Medical Research | Warwick | Rhode Island | — | — |
| Clinical Research Solutions, LLC | Franklin | Tennessee | — | — |
| Clinical Research Associates, Inc | Nashville | Tennessee | — | — |
| Foothill Family Clinc South, J. Lewis Research Inc. | Salt Lake City | Utah | — | — |
| Foothill Family Clinic, J. Lewis Research Inc. | Salt Lake City | Utah | — | — |
| Jordan River Family Medicine, J. Lewis Research, Inc. | South Jordan | Utah | — | — |
| Clinical Research Associates | Norfolk | Virginia | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02256488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 11, 2019 · Synced Nov 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02256488 live on ClinicalTrials.gov.